The European Medicines Evaluation Agency: Open To Criticism

October 02, 1998

(The European Medicines Evaluation Agency: open to criticism)

In an editorial in this week's BMJ Dr Kamran Abbasi, Assistant Editor of the BMJ and Dr Andrew Herxheimer, of the UK Cochrane Centre, argue that the European Medicines Evaluation Agency (EMEA) needs an independent and more thorough system of data collection and appraisal so that doctors and patients can have greater confidence in the drug licensing system. The authors say that the present system of withholding information that is deemed to be commercially confidential (sometimes as little as one per cent of the information about a product that the agency holds, is released into the public domain) strengthens manufacturers' commercial interests at the expense of public confidence.

In the European Union, drugs may be licensed in three ways. The centralised procedure allows applications to be made direct to the EMEA so that drugs can be made available throughout the European Union. Alternatively companies can apply to national licensing authorities, which ensures that product licences granted in one country receive mutual recognition in other member states. Lastly, if a product is to be marketed in a single country, an application can be made to the licensing authority of that country under a national procedure.

Dr Kamran Abbasi, Assistant Editor, BMJ, Tavistock Square, London


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